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Session 9: Track 4: eSubmissions Revolution 2.0: Leveraging Lessons of Today’s Standards Implementations to Prepare for Increased Use
Session Chair(s)
Stacy Tegan
Program Director
Transcelerate Biopharma, Inc., United States
It’s been almost 20 years since submissions were revolutionized to become “electronic.” Since that time, the way we access and consume information in every aspect of our lives has changed dramatically. It’s time for another revolution for submissions – one that will leverage structured contact and data standards. What changes are coming? What lessons of experience can we apply in the future? Session includes a case study of SEND standard implementation.
Learning Objective : At the conclusion of this session, participants should be able to:Explain how structured information improves regulatory review and describe potential areas for expanded use of standards and structured content
Speaker(s)
Standards Implementation: BMS Case Study and Plans for Expanding Use of SEND
Katherine Dubrow
Bristol Myers Squibb, United States
Research Scientist
eSubmission Evolution: Structured Data and Data Standards
Jared Lantzy, PMP
Booz Allen Hamilton, United States
Lead Associate
SEND: What is it and Where Are We as an Industry?
Fred Wood, PhD, MS
Data Standards Consulting Group, A Division of TalentMine, United States
Vice President, Consulting Services
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